National Head of OCS Kidney Program

TransMedics, Inc.•Andover, MA

1d•$408,150 - $509,050

About The Position

TransMedics is creating a surgical and clinical leadership role to lead execution of its OCS Kidney Program. The Head of the OCS Kidney Program is accountable for the program’s preclinical and clinical work, including development of the clinical use model, clinical development, interactions with the FDA and international regulatory bodies, and commercial launch in the U.S. and Europe. The role partners with all functional areas and shares accountability for clinical trial success, global revenue and volume targets, customer adoption, and long-term program success. The role owns clinical input into product development and design validation; preclinical studies needed to support first-in-human trials; clinical trial protocols and statistical analysis plans; surgical and clinical training; and clinical requirements for digital control, remote monitoring, user experience, and future product improvements. It also leads clinical engagement with trial sites and users, supports trial enrollment, data quality, regulatory presentations, and clinical data interpretation. The role builds relationships with clinicians, hospital systems, and OPOs; supports global commercial introduction and adoption; monitors utilization, issues, and feedback; and leads clinical assessment of field and user complaints with Quality. Additional duties include participation in strategic leadership meetings and liver and kidney donor procurement missions in the Northeast region or elsewhere as needed. This is an executive role with 24/7 accountability. The position participates in an executive on-call escalation rotation, must be reachable during active critical cases, requires regular presence in the Clinical Command Center, and involves travel to transplant centers, OPOs, and industry meetings, as well as occasional observation of clinical procedures.

Requirements

MD with advanced surgical training in abdominal organ transplantation.
At least 7 years of independent surgical experience, including abdominal organ procurement.
Uphold the highest moral and ethical standards.
Proven leadership ability to build, manage, and develop teams while fostering engagement and accountability.
Exceptional customer-facing skills and demonstrated ability to engage clinical staff at sites and advocate for the OCS platform.
Ability to lead teams calmly and decisively with clear direction in time-sensitive, mission-critical environments.
Exceptional interpersonal and communication skills, including the ability to communicate effectively with internal teams and clinical sites at all organizational levels.
Detail-oriented, highly organized, hands-on self-starter.
Proven ability to collaborate effectively across functions and all levels of the company.
Track record of successfully managing complex clinical and/or commercial programs and projects.
Demonstrated ability to perform in a fast-paced, dynamic environment under the time and stress constraints inherent to donor surgery and organ transplantation.
Maintain surgical availability to meet mission demand and provide the highest quality surgical service.
Maintain zero tolerance for ethical, moral, or interpersonal misconduct.

Responsibilities

Own clinical input into OCS Kidney product development, design validation, and regulatory readiness.
Optimize and refine the clinical use workflow and model in alignment with product design, workflow requirements, and clinical practice.
Own the design and execution of preclinical studies required by U.S. and international regulatory bodies to enable the first-in-human clinical trial.
Develop clinical trial protocols and statistical analysis plans in partnership with Clinical Affairs and Regulatory leadership.
Develop and execute surgical and clinical training requirements and protocols for internal and external OCS Kidney System users.
Define clinical requirements for OCS Kidney digital control, remote monitoring, user experience, and future product improvements in partnership with Digital Development and using customer feedback and usability findings.
Partner in selecting initial global clinical trial centers and lead clinical outreach with Commercial and Clinical Affairs.
Own engagement and relationships with surgical leaders at all U.S. trial centers.
Represent the program clinically before the CEC and DSMB for OCS Kidney trials.
Be accountable for trial enrollment targets and timely collection and cleaning of trial data with Clinical Affairs to support regulatory submissions.
Own clinical communications to trial sites regarding trial progress.
Lead clinical data presentations to U.S. and international regulatory bodies and clinical users, and lead interpretation and positioning of data for final clinical study reports.
Build and maintain relationships with global OCS Kidney System users, including clinicians, hospital systems, and OPOs.
Plan and execute OCS Kidney user and investigator meetings.
Partner with the Commercial team to introduce the OCS Kidney System to clinical programs globally.
Monitor and report system utilization, device-related issues, user feedback, and other clinically relevant information to stakeholders.
Lead clinical assessment of field and user complaints through resolution in partnership with Quality.
Develop and own clinical content for customer communications, including PIBs, Clinical Use Models, and field notifications.
Support scientific presentations and draft clinical abstracts and publications for OCS Kidney users.
Participate in strategic leadership meetings focused on the OCS Kidney program.
Perform liver and kidney donor procurement missions in the Northeast region or elsewhere as needed.
Perform other TransMedics duties as assigned.
Participate in the executive on-call escalation rotation, remain reachable during active critical cases, maintain regular presence in the Clinical Command Center, and travel to transplant centers, OPOs, and industry meetings.